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Sponsored by: |
Minnesota Veterans Research Institute |
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Information provided by: | Minnesota Veterans Research Institute |
ClinicalTrials.gov Identifier: | NCT00631436 |
Brain injury from explosive blast is a prominent feature of contemporary combat. Although protective armor and effective acute medical intervention allows soldiers to survive blast events, a growing number of veterans will have disability stemming from blast-related neural damage. Soldiers also return from combat with psychological disabilities caused by traumatic war events. The clinical presentation of individuals with blast-related neural damage and post-traumatic psychopathology are markedly similar and thus a clear description of the direct consequences of explosive blast is complicated by the emotional and cognitive sequelae of psychological trauma. We will use sophisticated measures of neural function and structure to characterize brain injury from explosive blasts in a sample of Operation Iraqi Freedom (OIF) National Guard soldiers who returned from deployment in the fall of 2007. Survey data gathered near the end of deployment indicated that over 50% of the brigade had been exposed to direct physical effects of explosive blasts. To fully characterize the effects of blast on the brain and differentiate them from post-traumatic stress disorder, we will contrast groups of soldiers exposed to blast and with groups experiencing post-traumatic stress disorder. This investigation will improve the characterization of blast-related traumatic brain injury, describe the essential features of the condition in terms of neural function and structure to inform diagnosis, and characterize mechanisms of recovery after blast-related neural injury to allow the creation of interventions that return soldiers to maximum levels of functioning.
Condition |
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Blast Injuries Traumatic Brain Injury Post-Traumatic Stress Disorders |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | The Effects of Explosive Blast as Compared to Post-Traumatic Stress Disorder on Brain Function and Structure |
Whole blood samples and isolated DNA and serum
Estimated Enrollment: | 180 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
If the individuals who meet the blast exposure criteria have a PCL score above 50 and meet the Hoge et al PCL criteria, thus indicating likely PTSD, they will be invited to participate as members of the Blast Exposed + PTSD group.
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2
Other individuals meeting the blast exposure criteria will be invited to participate in the as members of the Blast Exposed + No PTSD group if they have PCL scores below 30.
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3
Individuals reporting that they were not exposed to explosive blast will be recruited to participate. Those not exposed to blast but with PCL scores over 50 and meeting the Hoge et al PCL criteria will be invited to participate as members of the No Blast + PTSD group.
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4
Individuals not exposed to blast with PCL scores below 30 will be invited to participate as members of the No Blast + No PTSD group.
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Background: The clinical presentation of individuals with blast-related brain injury and post-traumatic stress reactions can be markedly similar and thus a clear description of the direct consequences of explosive blast is complicated by the emotional and cognitive sequelae of psychological trauma. The inability to clearly separate the basis of symptoms for the two conditions has hampered clinicians in prescribing effective treatments that return soldiers to maximal functioning. Measures that directly assess neural disruption may be employed to differentiate blast-related brain injury from post-traumatic psychopathology and guide effective intervention..
Objective/Hypothesis: We propose to use quantitative indices of brain electrical activity and diffusion tensor imaging (DTI) to characterize the effects of blast injury on brain function and structure. We hypothesize that Operation Iraqi Freedom (OIF) soldiers injured by explosive blast will be distinguishable from those with post-traumatic stress disorder (PTSD) on measures of brain function and structure. Specifically, blast exposure will be associated with diminished P3a amplitudes to target stimuli during sustained attention and diminished lateralized frontal potentials during recognition of previously presented words. Individuals with PTSD will exhibit normal amplitudes of P3 and lateralized frontal brain potentials. Blast affected soldiers will also have compromised white matter integrity in supracallosal, inferior frontal, and superior frontal brain regions while PTSD will not be associated with these structural abnormalities. Finally, functional brain anomalies (e.g., P3a), and frontal white matter fractional anisotropy will be associated with the adaptive functioning of soldiers.
Specific Aims: Using advanced quantitative analyses of electroencephalogram recordings we will determine the nature of functional neural anomalies related to sustained attention and memory deficits evident after injury from blast. We will determine white matter anomalies that are unique to blast injury as compared to PTSD. We will also determine which aspects of blast-related functional and structural brain abnormalities are associated with adaptive functioning in post-deployment. The long-term goals for the proposed program of research are to improve the characterization of traumatic brain injury (TBI) due to blast, describe its essential features in terms of neural function and structure to improve diagnosis, and characterize mechanisms of recovery after blast-related neural injury to facilitate the creation of interventions that target pathophysiology.
Study Design: In May of 2007 over 2650 Minnesota National Guard troops of the 1/34 BCT completed a within-theatre survey on health, exposure to blast, and traumatic events. Fifty-one percent of surveyed troops reported being close enough to an explosive blast that they felt a heat or pressure wave, had trouble hearing, or had subsequent problems with attention or memory. The proposed study will be carried out over a four-year period and include a total of 180 subjects. To determine the neural consequences of blast exposure we will compare the functional and structural brain characteristics of individuals from the 1/34 BCT who have blast injury, blast injury and PTSD, PTSD, and no blast injury or PTSD. There will be 45 demographically similar subjects in each group.
Ages Eligible for Study: | 20 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
National Guard Soldiers
Inclusion Criteria:
Exclusion Criteria:
Contact: Scott R Sponheim, Ph.D. | 612-467-3916 | sponh001@umn.edu |
United States, Minnesota | |
Minneapolis VA Medical Center | |
Minneapolis, Minnesota, United States, 55417 |
Principal Investigator: | Scott R Sponheim, Ph.D. | Minneapolis Veterans Affairs Medical Center |
Responsible Party: | Minneapolis VA Medical Center ( Scott Sponheim ) |
Study ID Numbers: | PT074550, CDMRP PT074550 |
Study First Received: | February 28, 2008 |
Last Updated: | March 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00631436 |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
Diffusion Tensor Imaging Electroencephalography Blast Injury Traumatic Brain Injury |
Craniocerebral Trauma Blast Injuries Wounds and Injuries Stress Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
Brain Diseases Stress Disorders, Traumatic Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Brain Injuries |
Barotrauma Pathologic Processes Disease Nervous System Diseases |